Description
Regulatory Affairs Specialist
Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist for our client a leading medical device Bridgewater, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Six month assignment
Pay is $31-33 an hour
HYBRID role - 3 days in the office
Overview
Responsible for providing Regulatory Affairs support to International RA Teams for product registrations, renewals to global markets for all US approved/cleared products including pharmaceuticals, medical devices, nutritional's and skin care products.
Requirements
- provide support for all requested documents (certificates/letters) search and retrieve support documentation including product labels, certificates, letters and product support documentation.
- Triage requests to other functional groups or obtain information for regions that cannot be located in the information systems that are in place (GDMS D2, Docubridge, etc.).
- Work with other functional team members to coordinate information needed and offer assistance in solving issues and clarifying needs.
- Continue to manage MOB projects on an as-needed basis.
- Work with other International Support groups (Operations, QA, etc.) to provide assistance to regions.
- On Site administrative support with, approvals, dispatch and coordinating hardcopy file movement from international requestors to approval bodies and returns
- Requirements: BSC in Biological Sciences or Regulatory Affairs, MSC Preferred.
- Minimum 2-4 years work experience in Global/ International Regulatory affairs.
- Legal Administration experience Preferred or equivalent.
Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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